Treatment of Traumatic Brain Injury With Hyperbaric Oxygen Therapy

NCT00810615 | Completed Phase 1 Results DMC

• 1 other identifier: FWH20080137H
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine if hyperbaric oxygen therapy (HBOT) improves the cognitive function of OIF/OEF individuals who have chronic mild to moderate traumatic brain injury (TBI). Cognitive function includes such things as thinking, remembering, recognition, concentration ability and perception. Traumatic brain injury is common with head injuries caused by blows to the head, nearby explosions, or concussion. Subjects will be assigned to an intervention or sham arm. Computer based cognitive tests will be used as outcome measures. Subjects are enrolled by invitation only.

Conditions

Brain Injury, Chronic

Keywords

chronic TBI; cognitive function; PTSD; HBO; hyperbaric; oxygen; chronic brain injury

Outcome Measures

Primary Outcomes (11)

• Computer Cognitive Test Scores - ImPACT Verbal Memory

  The Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) battery was developed at the University of Pittsburgh. It has a sensitivity of 81.9% and specificity of 89.4% in discriminating between concussion and non-concussion groups. It consists of a medical history questionnaire regarding concussions and resultant symptoms including loss of consciousness, memory loss, confusion, headache, seizure activity, emotional state, and sleep patterns. There are four subtests given and scored by computer. These include verbal and visual memory, visual motor speed, and response time. The composite scores are specifically designed to determine changes within the individual, better or worse, over time. The verbal memory score demonstrates improvement as the score increases. The score range was 36.8 to 98.6.

  Baseline and six weeks post hyperbaric exposure series

• Posttraumatic Stress Disorder Checklist - Military Version (PCL-M) Scores

  The PCL-M is a self reported test in which a list of 17 problems and complaints are offered to the individual to score on a 1 to 5 scale with 1 designating "not at all", 2= "a little bit", 3= "moderately", 4= "quite a bit" and 5 designating "extremely". A sample complaint would be "repeated, disturbing dreams of a stressful military experience". Hence there is a possible total score range from 17 to 85. For military members, a score of 50 or above is indicative of PTSD. A change from baseline of 5-9 represents a reliable change and change of 10 or greater is a significant change.

  baseline compared to the change at post hyperbaric exposures (30) series and the six weeks post hyperbaric exposure series

• Computer Cognitive Test Scores - ImPACT Visual Memory

  The Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) battery was developed at the University of Pittsburgh. It has a sensitivity of 81.9% and specificity of 89.4% in discriminating between concussion and non-concussion groups. It consists of a medical history questionnaire regarding concussions and resultant symptoms including loss of consciousness, memory loss, confusion, headache, seizure activity, emotional state, and sleep patterns. There are four subtests given and scored by computer. These include verbal and visual memory, visual motor speed, and response time. The composite scores are specifically designed to determine changes within the individual, better or worse, over time. The visual memory score demonstrates improvement as the score increases. The score range was 31.2 to 92.7.

  Baseline and six weeks post hyperbaric exposure series

• Computer Cognitive Test Scores - ImPACT Processing Speed

  The Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) battery was developed at the University of Pittsburgh. It has a sensitivity of 81.9% and specificity of 89.4% in discriminating between concussion and non-concussion groups. It consists of a medical history questionnaire regarding concussions and resultant symptoms including loss of consciousness, memory loss, confusion, headache, seizure activity, emotional state, and sleep patterns. There are four subtests given and scored by computer. These include verbal and visual memory, visual motor speed, and response time. The composite scores are specifically designed to determine changes within the individual, better or worse, over time. The Processing Speed score demonstrates improvement as the score increases. The score range was 9.7 to 52.4.

  Baseline and six weeks post hyperbaric exposure series

• Computer Cognitive Test Scores - ImPACT Reaction Time

  The Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) battery was developed at the University of Pittsburgh. It has a sensitivity of 81.9% and specificity of 89.4% in discriminating between concussion and non-concussion groups. It consists of a medical history questionnaire regarding concussions and resultant symptoms including loss of consciousness, memory loss, confusion, headache, seizure activity, emotional state, and sleep patterns. There are four subtests given and scored by computer. These include verbal and visual memory, visual motor speed, and response time. The composite scores are specifically designed to determine changes within the individual, better or worse, over time. The reaction time score demonstrates improvement as the score decreases. The score range was 0.42 to 1.84.

  Baseline and six weeks post hyperbaric exposure series

• Computer Cognitive Test Scores - BrainCheckers Simple Reaction Time

  Braincheckers is a PDA version of the Automated Neuropsychological Assessment Metrics (ANAM) supported by the Army Medical Research and Materiel Command in 2000. It was validated against ANAM for the individual tests used. Throughput is defined as correct responses per minute of time available to respond. Higher scores indicate higher accuracy in each of the subtest. The simple reaction time range is 30 to 255.

  Baseline and six weeks post hyperbaric exposure series

• Computer Cognitive Test Scores - BrainCheckers Code Substitution

  Braincheckers is a PDA version of the Automated Neuropsychological Assessment Metrics (ANAM) supported by the Army Medical Research and Materiel Command in 2000. It was validated against ANAM for the individual tests used. Throughput is defined as correct responses per minute of time available to respond. Higher scores indicate higher accuracy in each of the subtest. The range is 9 to 66. The scores in this section represent results of the code substitution subtest.

  Baseline and six weeks post hyperbaric exposure series

• Computer Cognitive Test Scores - BrainCheckers Procedural Reaction Time

  Braincheckers is a PDA version of the Automated Neuropsychological Assessment Metrics (ANAM) supported by the Army Medical Research and Materiel Command in 2000. It was validated against ANAM for the individual tests used. Throughput is defined as correct responses per minute of time available to respond. Higher scores indicate higher accuracy in each of the subtest. The range is 25 to 118. The scores in this section represent results of the procedural reaction time.

  Baseline and six weeks post hyperbaric exposure series

• Computer Cognitive Test Scores - BrainCheckers Go-NoGo Reaction Time

  Braincheckers is a PDA version of the Automated Neuropsychological Assessment Metrics (ANAM) supported by the Army Medical Research and Materiel Command in 2000. It was validated against ANAM for the individual tests used. Throughput is defined as correct responses per minute of time available to respond. Higher scores indicate higher accuracy in each of the subtest. The range is 41 to 174. The scores in this section represent results of the Go-NoGo reaction time subtest.

  Baseline and six weeks post hyperbaric exposure series

• Computer Cognitive Test Scores - BrainCheckers Matching To Sample

  BrainCheckers is a PDA version of the Automated Neuropsychological Assessment Metrics (ANAM) supported by the Army Medical Research and Materiel Command in 2000. It was validated against ANAM for the individual tests used. Throughput is defined as correct responses per minute of time available to respond. Higher scores indicate accuracy in each of the subtest. The range is 6 to 50. The scores in this section represent results of the matching to sample subtest.

  Baseline and six weeks post hyperbaric exposure series

• Computer Cognitive Test Scores - BrainCheckers Code Sub Recall

  BrainCheckers is a PDA version of the Automated Neuropsychological Assessment Metrics (ANAM) supported by the Army Medical Research and Materiel Command in 2000. It was validated against ANAM for the individual tests used. Throughput is defined as correct responses per minute of time available to respond. Higher scores indicate accuracy in each of the subtest. The range is 6 to 135. The scores in this section represent results of the code sub recall subtest.

  Baseline and six weeks post hyperbaric exposure series

Secondary Outcomes (2)

• Functional MRI

  six weeks post hyperbaric exposure series

• Stem Cells: CD_34

  six weeks post hyperbaric exposure series

Study Arms (2)

Sham treatment

SHAM COMPARATOR

Subject will breathe air at less than 1.3 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at less that 1.3 ATA. Hyperbaric exposures will be done up to 5 times per week with a total number of 30 exposures.

Other: Sham treatment

Hyperbaric oxygen 2.4 ATA

EXPERIMENTAL

Subject will breathe 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. Hyperbaric exposures will be done up to 5 times per week with a total number of 30 exposures.

Other: Hyperbaric oxygen @ 2.4 ATA

Interventions

Hyperbaric oxygen @ 2.4 ATA OTHER

Subject will breath 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. Hyperbaric exposures will be done up to 5 times per week with a total number of 30 exposures.

Also known as: hyperbaric oxygen, HBOT, HBO

Hyperbaric oxygen 2.4 ATA

Sham treatment OTHER

Also known as: sham exposure; 1.3 ATA air

Sham treatment

Eligibility Criteria

• Age: 19 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• neurology diagnosis of mild to moderate TBI
• injury sustained during OIF/OEF military activities
• perception of cognitive dysfunction following their injury
• stable mental status for at least two months
• stable psychotropic medication history for at least one month
• ability to perform computer based cognitive testing (must be capable using a mouse and PDA pointer and readily view the displays)
• TBI occurrence since 7 October 2001
• ability to consent

You may not qualify if:

• medical conditions that prevent subject from participating in hyperbaric environments
• previous hyperbaric oxygen treatments since being diagnosed with TBI
• history of alcohol abuse
• history of drug abuse

Sponsors & Collaborators

• San Antonio Military Medical Center: lead

MeSH Terms

Conditions

Brain Injury, Chronic; Stress Disorders, Post-Traumatic

Interventions

Hyperbaric Oxygenation

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Injuries; Craniocerebral Trauma; Trauma, Nervous System; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wounds and Injuries; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics

Limitations and Caveats

Caveats: Analysis used both repeated measures of analysis of covariance (ANCOVA) and repeated measures analysis of variance (RMANOVA). Due to the results, analysis is currently identifying potential subgroups which may demonstrate significance.

Results Point of Contact

• Title: Dr. George Wolf, Associate Investigator
• Organization: San Antonio Military Medical Center, Wilford Hall Ambulatory Surgical Center

earl.wolf.ctr@us.af.mil

210-292-3483

Study Officials

• E. George Wolf, M.D.

  SAMMC Hyperbaric Medicine

  STUDY DIRECTOR

• Leonardo C Profenna, M.D.

  SAMMC Hyperbaric Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Director

Study Record Dates

• First Submitted: December 17, 2008
• First Posted: December 18, 2008
• Study Start: February 1, 2009
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: August 13, 2018
• Results First Posted: August 13, 2018

Record last verified: 2017-11